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Not yet recruitingNCT07661134Updated Jun 22, 2026

Effect of Low Energy Extracorporeal Shockwave on Patients With Bell's Palsy

An interventional study of Low energy extracorporeal shockwave therapy and Selective physical therapy program in Bell Palsy, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
45 Years to 55 Years
Sex
All
01

Study summary

This study aims to investigate the effect of low energy extracorporeal shock wave therapy on patients with Bell's palsy.

Read the detailed description

Bell's palsy may range in severity from near-normal facial function to crippling facial disfigurement. It severity has been recognized to influence patient perceived quality of life to varying degrees. It yields myriad deficits affecting form and function. It can be a devastating and disfiguring condition, leading to psychological difficulties and restrictions of facial expressions, and may have a dramatic impact on interpersonal relationships. Facial nerve paralysis (FNP) often causes decreased quality of life and may lead to significant facial dysfunction. It is a health issue causing concern and has an extremely negative effect on both patients and their families. Main goals of treatment are to speed recovery, to make recovery more complete, to prevent corneal complications and other sequelae, and to inhibit viral replication. Psychological support is also essential. Patients require regular follow ups. Patients with Bell's palsy should be referred to a specialist and treatment should start as soon after onset as possible. In recent studies on peripheral nerves injuries, Low energy extracorporeal shock wave is a new tool for management. Extracorporeal shock wave therapy not only used in (urinary stone lithotripsy treatment, in the musculoskeletal field (lateral and medial epicondylitis, plantar fasciitis, calcific tendinitis of the shoulder, and bony union after fracture), muscle rigidity, muscular pain, knee degenerative arthritis, and lymphedema), but also used in regeneration of peripheral nerves. It causes molecular and biological changes, in addition to mechanical and physical stimulation. So in this study, we aim to determine the effect of low energy extracorporeal shock wave on Bell's palsy patients.

02

Conditions studied

  • Bell Palsy

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03

In context

Bell Palsy

85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.

This study's planned enrollment of 42 is close to the median of 42 across 70 interventional studies indexed under Bell Palsy.

Browse Bell Palsy studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with unilateral Bell's palsy (only lower motor neuron lesion).
  • Patient with idiopathic or viral infection, Bell's palsy.
  • The age ranged from 45 to 55 years old.
  • Both males and females are included.
  • (18.5-29.9kg/m2).
  • It includes the patient in the chronic stage.
  • All patients are assessed by NCS and other functional scales.
  • All patients will be referred by neurological consultants.
  • All patients have controlled diabetes mellitus and are medically stable.

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of facial paralysis post-stroke.
  • Patients with unstable medical conditions.
  • Patients with psychiatric disorders.
  • Patients with other neurological diseases.
  • Patients with other causes for Bell's palsy.
  • Patients with diabetic diseases.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Low energy extracorporeal shockwave therapy + Selective physical therapy program

    This group will receive low energy extracorporeal shockwave therapy in addition to a selective physical therapy program (therapeutic exercise plus massage), 2 sessions per week for 6 weeks.

    Device: Low energy extracorporeal shockwave therapy · Other: Selective physical therapy program

  • Active comparator
    Selective physical therapy program

    This group will receive a selective physical therapy program (therapeutic exercise plus massage), 2 sessions per week for 6 weeks.

    Other: Selective physical therapy program

Interventions

  • DeviceLow energy extracorporeal shockwave therapy

    Participants allocated to the experimental group will receive low-energy extracorporeal shockwave therapy (LE-ESWT) using a shockwave device set at a frequency of 10 Hz, energy intensity of 2.5, and a total dose of 2500 shockwaves per session. The treatment will be delivered to two sites along the facial nerve pathway, including the stylomastoid foramen (500 shockwaves) and a point located 1 cm anterior to the ear (2000 shockwaves). Each session will be administered for approximately 15 minutes throughout the intervention period.

  • OtherSelective physical therapy program

    Participants will receive a standardized physical therapy program including neuromuscular reeducation and massage therapy. Facial exercises will be performed in front of a mirror to improve symmetry and facial muscle control, with therapist assistance provided as needed. Massage therapy will be applied to the neck, scalp, and facial regions. Each treatment session will last approximately 30 minutes.

06

What researchers measure

Primary outcomes

  1. CMAP Amplitude Asymmetry Percentage

    Facial nerve function will be assessed using nerve conduction studies (NCS). Compound muscle action potential (CMAP) amplitudes will be recorded bilaterally by stimulating the facial nerve anterior to the mastoid process and recording responses from the nasalis muscle. The percentage of CMAP amplitude asymmetry between the affected and unaffected sides will be calculated as \[(CMAP amplitude affected side - CMAP amplitude unaffected side)/CMAP amplitude unaffected side\] × 100. Lower asymmetry values will indicate improved facial nerve conduction and recovery. Assessments will be performed at baseline and after completion of the treatment program.

    Time frame: 6 weeks

Secondary outcomes

  1. House-Brackmann Facial Nerve Grading Scale

    Facial function will be evaluated using the House-Brackmann (HB) Facial Nerve Grading Scale, a validated six-grade clinical assessment tool ranging from Grade I (normal facial function) to Grade VI (total facial paralysis). The scale assesses facial symmetry at rest and voluntary facial movements, providing an overall measure of facial nerve dysfunction severity. Lower HB grades will indicate better facial function and recovery. Assessments will be conducted at baseline and following completion of the treatment program.

    Time frame: 6 weeks

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Sep 2026, 3 months later.

Of 38 non-industry interventional studies with no phase under Bell Palsy, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's planned 3 months is below that.

Counting every sponsor, half of 40 studies reached it within 10 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 16, 2026
First posted
Jun 22, 2026
StartEst.
Jun 25, 2026
Primary completionEst.
Sep 25, 2026
CompletionEst.
Sep 30, 2026
Last update
Jun 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07661134
Lead sponsor
Cairo University
Responsible party
Dina Hamdy Mahmoud Abd el Aziz (Principal Investigator, Cairo University) — Principal investigator
First posted
Jun 22, 2026
Start date
Jun 25, 2026 (estimated)
Primary completion
Sep 25, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jun 22, 2026

Study contacts

Dina Hamdy Mahmoud Abd el Aziz, B.Sc
Contact
dinamahmoud11289@gmail.com
+20 10 31190767
Rasha Mohamed El Rewiny, PhD
Contact
Rasha Mohamed El Rewiny, PhD
study chair · Ass. Professor, Cairo University
Ebtsam Mohamed Fahmy, PhD
study director · Professor, Cairo University
Mohamed Helayel Marzouk Helayel, PhD
study director · Lecturer, Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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